Stem cell meeting focuses on business

Point Loma  Stem cell science is at last moving into clinical trials. But delivering its results to patients will require huge investments by drug and biotech companies, and health insurers must decide on how to reimburse for such therapy.

Just how that’s going to happen is part of the Stem Cell Meeting on the Mesa, which begins Monday and ends Wednesday. The annual conference, which began as a scientific symposium, has extended into business matters as research get closer to patient treatments.

The meeting in La Jolla includes scientific updates on stem cell research and presentations from more than 50 companies and research institutes, seeking investment or offering their science skills.

The business push into what’s called regenerative medicine takes place as the United States is adopting a new health care system. Biotech executives speaking at the conference said their job is to document the benefits in restoring patient health and replacing less effective and more costly alternatives.

Regenerative medicine aims to do what until very recently has been impossible: regrow lost tissues or organs and reverse degenerative diseases such as Parkinson’s. The need for such treatments is becoming greater as baby boomers reach retirement age, and thousands of young veterans struggle with disabling injuries.

The field faces the same business challenges as any new area of medicine, said Perry Karsen, executive vice president of Celgene Corp. The biotech giant is based in Summit, N.J., and has an office in San Diego.

“It’s a new area of science. It’s very similar to what we saw with monoclonal antibodies 20-25 years ago,” Karsen said.

Monoclonal antibody drugs represent one of biotech’s biggest success stories. They include drugs such as Humira, for autoimmune diseases, which brought in $9.3 billion in 2012. But many early attempts to develop monoclonal drugs failed spectacularly. Making these drugs work well took years of persistence.

“Regenerative medicine is that next wave of innovation in the industry, and it has the same inherent risks as any new technology,” Karsen said.

Celgene is investing in regenerative medicine because it will transform how health care is practiced, Karsen said, declining to say how much the company is spending.

The new health care system will benefit regenerative medicine, because it encourages innovation that improves health, Karsen said.

“We see those innovations as contributing to patient health, longevity and allowing patients to resume their normal activities and being contributing members of society and taxpaying citizens,” he said.

But first, these therapies must be proven effective in clinical trials. Christopher Calhoun, chief executive of San Diego-based Cytori Therapeutics, said investors really begin to pay attention to a treatment after positive Phase 2 results are achieved in U.S. trials. Cytori makes a device that separates stem cells from fat. The stem cells are used for tissue repair and treating cardiovascular disease.

Successes for any company’s stem cell treatments are good for Cytori, Calhoun said, because the entire field needs the validation that the trials provide.

“I don’t look at the companies trying to develop the technologies as competitive today,” Calhoun said. “We need success in our field to create the data, the excitement, the awareness and the enthusiasm for this whole new field.”

Further down the road, health insurers will use this information to decide on reimbursement payments, said Michael Werner, executive director of the Alliance for Regenerative Medicine. The alliance is one of the meeting’s three sponsors, along with the Sanford Consortium for Regenerative Medicine, and the state’s stem cell agency, the California Institute for Regenerative Medicine.

“A lot of insurance decisions are made on actuarial data, so new technologies are sometimes hard to quantify for payers,” Werner said. “What makes regenerative medicine challenging is the same thing that makes it exciting. We’re talking about potentially really high-value products that are going after currently unmet medical needs, and diseases, disabilities and conditions that are currently untreatable.”

The meeting will be held at two locations; the Estancia La Jolla Hotel & Spa and the Salk Institute. More information is available at its website, stemcellmeetingonthemesa.com.